Apparatus and methods for sealing a vascular puncture

ABSTRACT

An apparatus for sealing a puncture includes a cartridge, a pusher member, a sealant, and a tamping device on a proximal end of the cartridge. During use, the cartridge, sealant, and pusher member are advanced over a positioning member and into the puncture by advancing a cartridge hub carrying the tamping device. When further distal advancement of the cartridge is limited, the cartridge hub is further advanced, activating the tamping device, and causing the pusher member to advance relative to the sealant to compress the sealant within the puncture.

RELATED APPLICATION DATA

This application claims benefit of provisional application Ser. No.61/114,049, filed Nov. 12, 2008, the entire disclosure of which isexpressly incorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates generally to apparatus and methods forsealing punctures in a body, and more particularly, to apparatus andmethods for sealing a vascular puncture extending through tissue into ablood vessel, and to apparatus and methods for delivering a plug,sealant, and/or other material into a percutaneous puncture extendingfrom a patient's skin to a blood vessel or other body lumen, e.g., toseal the puncture.

BACKGROUND

Apparatus and methods are known for accessing a patient's vasculaturepercutaneously, e.g., to perform a procedure within the vasculature, andfor sealing the puncture that results after completing the procedure.For example, a hollow needle may be inserted through a patient's skinand overlying tissue into a blood vessel. A guide wire may be passedthrough the needle lumen into the blood vessel, whereupon the needle maybe removed. An introducer sheath may then be advanced over the guidewire into the vessel, e.g., in conjunction with or subsequent to one ormore dilators.

A catheter or other device may be advanced through the introducer sheathand over the guide wire into a position for performing a medicalprocedure. Thus, the introducer sheath may facilitate accessing and/orintroducing various devices into the vessel, while minimizing trauma tothe vessel wall and/or minimizing blood loss. Upon completing theprocedure, the device(s) and introducer sheath may be removed, leaving apuncture extending between the skin and the vessel wall.

To seal the puncture, external pressure may be applied to the overlyingtissue, e.g., manually and/or using sandbags, until hemostasis occurs.This procedure, however, may be time consuming and expensive, requiringas much as an hour of a medical professional's time. It is alsouncomfortable for the patient, and may require the patient to remainimmobilized in the operating room, catheter lab, or holding area. Inaddition, a risk of hematoma exists from bleeding before hemostasisoccurs.

SUMMARY

The present invention is directed to apparatus and methods for sealing apuncture in a body, and, more particularly, to apparatus and methods forproviding temporary or permanent hemostasis within a vascular punctureextending into a blood vessel, and/or to apparatus and methods fordelivering a sealant and/or other material into a percutaneous punctureextending from a patient's skin to a blood vessel or other body lumen.

In accordance with one embodiment, an apparatus is provided for sealinga puncture extending through tissue that includes an elongate memberincluding a proximal end, a distal end sized for insertion into apuncture through tissue, and an expandable member on the distal end. Theapparatus also includes a cartridge including a proximal end, a distalend sized for insertion into the puncture, and a lumen extending betweenthe proximal and distal ends sized for receiving the elongate membertherein, a sealant disposed within the cartridge lumen adjacent thecartridge distal end, a pusher member disposed within the cartridgelumen adjacent to the sealant, and a tamping or auto advance device onthe cartridge proximal end for biasing the pusher member distallyrelative to the sealant when activated.

In accordance with another embodiment, an apparatus is provided forsealing a puncture extending through tissue. The apparatus may includean elongate member, a cartridge, a sealant disposed within thecartridge, a pusher member disposed within the cartridge adjacent to thesealant, and an auto advance device. The sealant may be positionedadjacent to a distal end of the cartridge and the auto advance devicemay be positioned on a proximal end of the cartridge. The elongatemember may optionally include a marker for indicating when the autoadvance device is in an active position.

In one embodiment, the auto advance device may include a cartridge huband a slider tube. The slider tube may be fixed to the cartridgeproximal end and may be slidable relative to the cartridge hub. The autoadvance device may further include a tamping spring and an auto advancespring. The tamping spring may be positioned between the pusher memberand a secondary pusher member and, optionally, may be compressiblebetween the pusher member and the secondary pusher member. The elongatemember may include an element for engaging with a latch element on thesecondary pusher member. The auto advance spring may be compressiblebetween the slider tube and an inner surface of the cartridge hub.

In another embodiment, the auto advance device may include a spring fordistally advancing the pusher member, thereby compressing the sealantbetween the pusher member and an expandable member on a distal end ofthe elongate member.

In accordance with yet another embodiment, a tamping apparatus isprovided for tamping a sealant delivered within a puncture. The tampingapparatus may include a housing, a slider tube, an auto advance spring,a tamping spring, and an auto advance spring tube. The slider tube isdisposed within the housing and may be slidable relative to the housingbetween an inactive position and an active position. In the inactiveposition, the tamping spring and the auto advance spring may beextended. In the active position, the tamping spring and the autoadvance spring may be compressed. The auto advance spring may becompressible between the slider tube and a proximal rib of the housingand may surround the auto advance spring tube. The tamping spring may bedisposed within the slider tube and coupled between a pusher tube and asecondary pusher tube. The apparatus may further include a tamping tubewithin the slider tube, and the tamping spring may be disposed withinthe tamping tube. The auto advance spring tube may be configured toprotrude into the slider tube, thereby distally advancing the secondarypusher tube and compressing the tamping spring. The secondary pushertube may include a latch element for engaging with a raised element onan elongate positioning member.

In accordance with still another embodiment, a method is provided forsealing a puncture extending through tissue to a body lumen. The methodmay include advancing a positioning member through the puncture until anexpandable element thereon is disposed within the body lumen, expandingthe expandable element within the body lumen, and retracting thepositioning member until the expanded expandable element contacts a wallof the body lumen adjacent the puncture. A cartridge, carrying asealant, a pusher member, and a proximal cartridge hub, may be advancedinto the puncture, e.g., over the positioning member until a distal endof the cartridge contacts the expandable element and/or an auto advancedevice in the cartridge hub is activated. The cartridge may be withdrawnfrom the puncture while maintaining the sealant and the pusher memberwithin the puncture, and the auto advance device may automaticallycompress the sealant within the puncture, e.g., between the pushermember and the expandable element.

In one embodiment, the cartridge hub may be advanced until a distal endof the cartridge contacts the expandable element, and then the cartridgehub may be advanced further to activate the auto advance device. Forexample, the auto advance device may include one or more biasingelements, e.g., a tamping spring and an auto advance spring, that may becompressed when the cartridge hub is advanced. The tamping spring may bepositioned between a pusher member and a secondary pusher member and alatch element on the secondary pusher member may engage with an elementon the positioning member during further advancing of the cartridge hub.Withdrawing the cartridge may expand the auto advance spring while thetamping spring may remain compressed. Tamping the sealant may includeexpanding a tamping spring, thereby advancing the pusher member furtherinto the puncture and compressing the sealant between the expandablemember and the pusher member.

In one embodiment, the method may further include collapsing theexpandable element and removing the positioning member from thepuncture, thereby withdrawing the collapsed expandable element throughthe sealant. The positioning member may optionally include a markerthereon and further advancing the cartridge hub may include advancingthe cartridge hub until a cartridge hub proximal end passes the marker,e.g., to provide a visual indicator that the cartridge hub has beenadvanced sufficiently to activate the auto advance device.

In accordance with yet another embodiment, a tamping mechanism isprovided that includes a middle hub, a housing, a spring biased so adistal end of the spring displaces a tamping device in a distaldirection, a latch coupled to the housing for engaging with a latchingdetent on the middle hub in one latch position and for engaging with thetamping device in another latch position, and a pusher member slidablydisposed within a proximal end of the middle hub, a proximal end of thepusher member for engaging with the tamping device. The pusher membermay be movable distally to tamp a sealant when the tamping device isreleased by the latch. The tamping mechanism may further include aspring clip for biasing the latch in the another latch position.

In accordance with still another embodiment, a tamping mechanism isprovided that includes a middle hub, a housing, a spring biased so adistal end of the spring displaces a tamping device in a distaldirection, a trigger pin slidably disposed within the housing, and apusher member slidably disposed within a proximal end of the middle hub.A proximal end of the pusher member may engage with the tamping device.The pusher member may be movable distally to tamp a sealant when thetamping device is released. The trigger pin may be moveable proximallyupon engagement with the middle hub, thereby releasing a stopper plate.In one embodiment, the tamping device includes a leaf spring fordisplacing the stopper plate in a position enabling distal movement ofthe tamping device. In another embodiment, the tamping device includes aspring biased hub latch for displacing the stopper plate in a positionenabling distal movement of the tamping device.

In accordance with yet another embodiment, a method is provided forsealing a puncture extending through tissue to a body lumen. The methodmay include advancing a positioning member through the puncture until anexpandable element thereon is disposed within the body lumen, expandingthe expandable element within the body lumen, and retracting thepositioning member until the expanded positioning element contacts awall of the body lumen adjacent the puncture.

A cartridge, carrying a sealant, a pusher member, and a proximalcartridge hub, may be advanced into the puncture until a distal end ofthe cartridge contacts the expandable element and/or an auto advancedevice in the cartridge hub is activated, e.g., by compressing a tampingspring and an auto advance spring in the auto advance device. Thecartridge may be withdrawn from the puncture while maintaining thesealant and the pusher member within the puncture, and the sealant maybe compressed within the puncture, e.g., between the pusher member andthe expandable element, by the auto advance device, e.g., by expandingthe tamping spring.

In accordance with still another embodiment, a method is provided forsealing a puncture extending through tissue to a body lumen. The methodmay include advancing a positioning member through the puncture until anexpandable element thereon is disposed within the body lumen, expandingthe expandable element within the body lumen, and retracting thepositioning member until the expanded positioning element contacts awall of the body lumen adjacent the puncture.

A cartridge, carrying a sealant and a pusher member, may be advancedinto the puncture until a distal end of the cartridge contacts theexpandable element and the pusher member is compressed between a catchon the positioning member and the sealant. An auto advance device on thecartridge is then activated, thereby allowing the compressed pushermember to expand axially and compress the sealant between the pushermember and the expandable element. For example, the pusher member mayinclude a tamping spring and the tamping spring may be compressed,thereby shortening the pusher member, yet biasing the pusher member toextend axially.

The cartridge may be withdrawn, leaving the sealant and pusher memberwithin the puncture. The expandable element may be collapsed and thepositioning member withdrawn, e.g., through the sealant and pushermember, whereupon the pusher member may be removed.

Other aspects and features of the present invention will become apparentfrom consideration of the following description taken in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of an exemplary embodiment of an apparatusfor delivering a sealant into a puncture through tissue, including acartridge carrying the sealant and a positioning member.

FIG. 1B is an exploded cross-sectional side view of a system fordelivering a sealant into a puncture through tissue, including theapparatus of FIG. 1A and an introducer sheath.

FIGS. 2A and 2B are cross-sectional views of a distal portion of theapparatus of FIGS. 1A and 1B, with the cartridge in proximal and distalpositions, respectively.

FIGS. 3A(1)-3A(3) are cross-sectional views of a hub of the cartridge ofFIG. 1A showing components of an auto advance device therein in aninactive position.

FIGS. 3B(1)-3B(3) are cross-sectional views of a hub of the cartridge ofFIG. 1A showing components of the auto advance device of FIGS.3A(1)-3A(3) in an active position.

FIGS. 4A, 5A, 6A, 7A, and 8A are partial cross-sectional views of apatient's body illustrating a method of using the system of FIG. 1A forsealing a puncture through tissue.

FIGS. 4B, 5B, 6B, 7B, and 8B are cross-sectional detail views of themethod of FIGS. 4A, 5A, 6A, 7A, and 8A.

FIGS. 6C and 6D are perspective views of a proximal end of a hub on thecartridge of the system of FIG. 1A before and after the hub passes amarker on the positioning member, respectively.

FIG. 9 is a cross-sectional view of another embodiment of an apparatusfor delivering sealant into a puncture through tissue, including atamping device.

FIGS. 10A-10B are cross-sectional views of the apparatus of FIG. 9 in afirst position.

FIGS. 11A-11B are cross-sectional views of the apparatus of FIG. 9 in asecond and a third position, respectively.

FIGS. 12A-12C are cross-sectional views of another embodiment of anapparatus for delivering sealant into a puncture through tissue,including a tamping device employing a latch gate configuration.

FIG. 13 is a cross-sectional view of another embodiment of an apparatusfor delivering sealant into a puncture through tissue, including atamping device in a position, similar to the embodiment shown in FIG.11B.

FIG. 14 is a cross-sectional view of yet another embodiment of anapparatus for delivering sealant into a puncture through tissue,including a tamping device in a position, similar to the embodimentshown in FIG. 11B.

FIGS. 15A-15C are cross-sectional views of an apparatus for delivering asealant device into a puncture through tissue including a tamping deviceemploying complementary latches.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

Turning to the drawings, FIGS. 1A and 1B show an exemplary embodiment ofan apparatus 101 and a system 10, respectively, for sealing a puncturethrough tissue. Generally, as shown in FIG. 1A, the apparatus 101includes a cartridge or other tubular member 120, and a positioning orocclusion member 140 including a positioning member housing 148. As bestseen in FIG. 1A, the cartridge 120 includes a sealant 2 therein, aplunger, tamping member, advancing member, or other pusher member 130carried by the cartridge 120, and a cartridge hub 123. As shown in FIG.1B, the apparatus 101 may be part of a system 10, e.g., which may alsoinclude a delivery, access, procedure, introducer, or other sheath 20.Optionally, the system 10 may include one or more other components,e.g., a needle, guidewire, and/or other instrument(s) for creating apuncture, a syringe or other source of inflation media and/or vacuum,and/or a source of additional sealing compound (not shown).

As best seen in FIG. 1B, the introducer sheath 20 may be a generallytubular body including a proximal end 22, a distal end 24 sized forinsertion into a puncture through tissue, and a lumen 26 extendingbetween the proximal and distal ends 22 and 24. The introducer sheath 20may be formed from a substantially rigid, semi-rigid, and/or flexibletubular body including a hub 23 on the proximal end 22. The introducersheath 20 may have sufficient length to extend from a patient's skinthrough any intervening tissue into a blood vessel or other body lumen,e.g., having a length between about ten centimeters and twentycentimeters (10-20 cm), and may have an outer diameter between about 1.6millimeters and four millimeters (1.6-4 mm). The distal end 24 may betapered and/or may include a substantially atraumatic distal tip 25 forfacilitating advancement through tissue and/or a puncture.

The introducer sheath 20 may be formed using known materials and/ormethods, e.g., plastic with the tubular body and hub 23 substantiallypermanently connected together, e.g., using one or more of aninterference fit, one or more mating connectors (not shown), bondingwith adhesive, sonic welding, and the like. The hub 23 generallyincludes one or more seals (not shown) adjacent an opening 27, which mayprevent flow of blood or other fluids out of the hub 23 from the lumen26, yet accommodate insertion of one or more instruments into the lumen26, such as the cartridge 120 and/or positioning member 140. Optionally,as shown, the hub 23 may include a side port 29 communicating with thelumen 26, e.g., for coupling a source of saline or other fluid (notshown) to the hub 23.

With additional reference to FIG. 1B, the cartridge 120 is generally anelongate tubular body including a proximal end 122, a distal end 124sized for introduction into the lumen 26 of the introducer sheath 20,and a lumen 126 extending between the proximal and distal ends 122, 124.The cartridge 120 may be substantially rigid, semi-rigid, or flexible,e.g., such that the cartridge 120 may be advanced through the introducersheath 20 or otherwise into a puncture through tissue. The cartridge 120may also include a tapered and/or substantially atraumatic distal tip125 and/or an enlarged handle or hub 123 on the proximal end 122. In oneembodiment, the hub 123 includes a tamping or auto-advance device, asdiscussed in more detail below.

Optionally, the system 10 may include a locking member (not shown) forcoupling the introducer sheath 20 to the cartridge 120 during use suchthat subsequent movement of the cartridge 120, e.g., proximally duringretraction, causes the introducer sheath 20 to be pulled or otherwisemoved along with the cartridge 120. This coupling may prevent accidentalproximal movement of the cartridge 120 independent of the introducersheath 20, which may otherwise result in deploying the sealant 2 fromthe cartridge 120 within the introducer sheath 20, rather than within apuncture itself. Exemplary embodiments of locking elements that may beused are disclosed in co-pending U.S. patent application Ser. No.11/864,835, filed Sep. 28, 2007, and published as U.S. Publication No.2009/0088793, the entire disclosure of which is hereby expresslyincorporated by reference.

The sealant 2 is provided within the distal portion of the cartridge 120and the pusher member 130 is provided proximal to the sealant 2 withinthe cartridge 120. The sealant 2 may include a biocompatible,bioabsorbable, and/or expandable material, such as a freeze-driedhydrogel. The sealant 2 may have a solid or hollow cylindrical shape, arolled sheet shape, a disk shape, or other shapes or cross-sections,such as elliptical, triangular, square, conical, disk, or polygonalshapes. For example, the sealant 2 may be formed from a solid materialincluding a lumen 4 extending between proximal and distal ends thereof,as shown in FIG. 1B. The lumen 4 may be created by rolling a sheet ofmaterial around a mandrel, by molding, by boring into, or otherwiseremoving material from an already formed solid material, and the like.The lumen 4 may be dimensioned such that the positioning member 140, aguidewire, and/or other instruments (not shown) may slide or otherwisepass through the sealant 2, as described elsewhere herein.

The sealant 2 may be substantially homogeneous or may include one ormore different materials at one or more locations. For example, in oneembodiment, the sealant 2 may include a carrier or core having first andsecond hydrogel precursors disposed thereon in an unreactive state,which may provide a “sticky” adherent coating when the sealant 2 isexposed to an aqueous environment. In one embodiment, the sealant 2 maybe formed from a biocompatible and/or bioabsorbable hydrogel, e.g.,polyethylene glycol (“PEG”), or other synthetic material. For example,the hydrogel may include a lyophilized (i.e., freeze-dried) PEG polymerthat includes hydrolytically degradable chemical groups, e.g., includinga macroporous polymer network, which may uptake fluid and expand whenexposed to an aqueous environment. The magnitude of expansion orswelling (pre to post hydration) may be significant, e.g., between abouttwo and ten times (2×-10×) its lyophilized size based on volume.

In addition or alternatively, the sealant 2 may include pro-thromboticmaterial, e.g., including one or more biological pro-thrombotics, suchas collagen, fibrin, carboxymethylcellulose, oxidized cellulose,alginates, gelatin, or other protein-based material, and/or syntheticmaterials, such as polyglycolic acids (PGA's), polyactides (PLA's),polyvinyl alcohol, and the like. Optionally, the sealant 2 may includeone or more therapeutic and/or pharmaceutical agents, e.g., to promotehealing, prevent infection, and/or other adverse medical events, and thelike. Such agents may be embedded in the sealant material and/or appliedas one or more coatings or layers. Exemplary materials and methods formaking and using them are disclosed in U.S. Pat. Nos. 6,152,943,6,165,201, 6,179,862, 6,514,534, 6,379,373, 6,703,047, 7,009,034,6,887,974, and in co-pending U.S. patent application Ser. No.10/454,362, filed Jun. 4, 2003, published as US 2004/0249342, Ser. No.10/982,387, filed Nov. 5, 2004, published as US 2006/0034930, Ser. No.10/982,384, filed Nov. 5, 2004, published as US 2006/0099238, and Ser.No. 11/465,791, filed Aug. 18, 2006 published as US 2007/0231366. Thedisclosures of these references are expressly incorporated by referenceherein.

The sealant 2 may be disposed within the lumen 126 of the cartridge 120proximate to the distal end 124, e.g., immediately adjacent the distaltip 125. Thus, when advanced into the introducer sheath 20 or otherwisewithin the puncture, the sealant 2 may remain out of direct or indirectcontact with blood or other bodily fluids along the blood path.Optionally, the cartridge 120 may include a split distal end (notshown), e.g., formed by creating one or more relatively shortlongitudinal cuts or slots extending proximally from the distal end 124.The split distal end may facilitate retraction of the cartridge 120relative to the sealant 2, e.g., by providing extra flexibility at thedistal end 124. Such cuts or slots may allow the distal end 124 toseparate more easily from the sealant 2, e.g., as the sealant begins toexpand upon being exposed to an aqueous environment, such as blood orother bodily fluids. The lumen 126 may be sized such that the cartridge120 and sealant 2 are slidable relative to one another, e.g., to allowthe cartridge 120 to be retracted proximally relative to the sealant 2and/or pusher member 130.

With further reference to FIG. 1B, the pusher member 130 may be anelongate tubular body, e.g., a plunger or catheter, including a proximalend 132, a distal end 134 sized for introduction into the lumen 126 ofthe cartridge 120, and a lumen 136 extending between the proximal anddistal ends 132, 134. The pusher member 130 may be sized for beingslidably received within the lumen 126 of the cartridge 120, althoughthe pusher member 130 may abut or otherwise interact with the hub 123 ofthe cartridge 120 such that the pusher member 130 is advanced distallywhen the cartridge 120 is advanced distally. The distal end 134 of thepusher member 130 may terminate in a substantially blunt distal tip 135,e.g., to facilitate contacting, pushing, advancing, tamping, and/or“cinching” the sealant 2 within a puncture, as described further below.In one embodiment, the proximal end 132 of the pusher member 130interacts with an auto-advance device in the hub 123, as discussed inmore detail below.

The pusher member 130 may be substantially rigid, semi-rigid, and/orsubstantially flexible, having sufficient column strength to allowproximal movement of the cartridge 120 relative to the sealant 2 withoutbuckling the pusher member 130 and/or to allow the distal tip 135 of thepusher member 130 to be “tamped” down on sealant 2 within a puncture,e.g., by pushing from the proximal end 132, as described elsewhereherein. The lumen 136 of the pusher member 130 may be sized toaccommodate the positioning member 140, a guidewire (not shown), aflowable sealing compound, and/or fluid therethrough. As explainedelsewhere herein, the pusher member 130 may include an axiallycompressible or foreshortenable portion, e.g., that may be compressed,yet is biased to extend axially towards its original length. Forexample, a tamping spring 210 may be provided adjacent the proximal end132 of the pusher member 130, e.g., between the proximal end 132 and asecondary pusher member 230. Alternatively, the tamping spring 210 maybe coupled to and extend from the proximal end 132 of the pusher member130 without the secondary pusher member 230. The tamping spring 210 maybe compressed by an auto advance device 200 (not shown, see FIGS. 3A-3B)within the hub 123 during use, thereby biasing the distal end 134 of thepusher member 130 to move distally, as explained further below.

With continued reference to FIGS. 1A and 1B, the positioning member 140generally is an elongate member including a proximal end 142, a distalend 144, a positioning or occlusion element 146 on the distal end 144,and a housing 148 on the proximal end 142. The positioning element 146may be an expandable member, such as a balloon, a wire mesh structure,an expandable frame, and the like. The positioning element 146 may beselectively expandable, e.g., using a source of inflation media, a pullwire, and/or other actuator (not shown), operable from the proximal end142 of the positioning member 140.

For example, as shown in FIGS. 1A and 1B, the positioning element may bea balloon 146, and the positioning member 140 may be a tubular bodyincluding a lumen (not shown) extending between the proximal and distalends 142, 144 and communicating with an interior of the balloon 146. Forexample, a syringe 149 (not shown, see FIGS. 4A, 5A, 6A) may communicatewith the housing 148 (and consequently the lumen and interior of theballoon 146) via tubing 147 connected to a port on the housing 148.Optionally, the positioning member 140 may include an internal pull wireand piston arrangement (not shown) that causes the balloon 146 toshorten during expansion and extend during collapse. Exemplaryembodiments of positioning members 140 including balloons that may beused are disclosed in co-pending U.S. patent application Ser. Nos.10/454,362, filed Jun. 4, 2003, published as US 2004/0249342, Ser. No.11/112,877, filed Apr. 22, 2005, published as US 2006/0253072, and Ser.No. 11/112,971, filed Apr. 22, 2005, and published as US 2008/0009794.The entire disclosures of these references are expressly incorporated byreference herein.

Alternatively, the positioning element 146 may be biased to an enlargedcondition, but may be compressed to a contracted condition, e.g., by anoverlying sleeve or other constraint (not shown). The constraint may beremoved to expose the positioning element, allowing the expandableelement to automatically expand to the enlarged condition. Additionalinformation on expandable structures that may be provided on thepositioning member 140 may be found in U.S. Pat. Nos. 6,238,412,6,635,068, and 6,890,343. The entire disclosures of these references areexpressly incorporated herein by reference.

Optionally, the positioning member 140 may include a transition cuff(not shown) on the distal end 144 adjacent and distal to the positioningelement 146. The transition cuff may comprise a flexible materialsimilar to the structure of material used in the positioning element146, e.g., as described elsewhere herein. The transition cuff mayprovide the apparatus 101 with a seal to minimize exposure of thesealant 2 to fluids during introduction and/or may provide an atraumatictip to lessen injury to the vessel during initial insertion of theapparatus 101 into the puncture and vessel. During expansion of thepositioning element 146, the transition cuff may be displaced off thedistal end of the positioning element 146 and fold adjacent to thepositioning element 146. A lubricious coating may be applied to thetransition cuff and/or positioning element 146 to ease the folding ofthe transition cuff during the expansion of the positioning element 146.Additional information on transition cuffs and systems and methodsincluding them may be found in co-pending application Ser. No.11/854,534, filed Sep. 12, 2007, published as U.S. Publication No.2008/0082122, the entire disclosure of which is expressly incorporatedby reference herein.

Turning to FIGS. 2A and 2B, the apparatus 101 may be used to positionand deliver the sealant 2 within a puncture, e.g., extra-vascularly justabove or otherwise adjacent to an arteriotomy in a blood vessel or otherbody lumen communicating with a puncture, as described further elsewhereherein. In one embodiment, as shown in FIG. 2A, the cartridge 120 (alongwith the pusher member 130 and sealant 2) may be initially provided onthe proximal end 142 of the positioning member 140. For example, thehousing 148 (not shown in FIGS. 2A and 2B, see FIG. 1A) on thepositioning member 140 and the hub 123 on the cartridge 120 may beinitially connected to one another, e.g., using one or more releasabledetents (not shown) and the like. The cartridge 120 may be slidabledistally along the positioning member 140, e.g., by disconnecting thehub 123 from the housing 148, and then advancing the hub 123 and thecartridge 120 until the distal end 124 of the cartridge 120 is disposedadjacent the positioning element 146, as shown in FIG. 2B. For example,the detents may simply separate from one another when the hub 123 isadvanced away from the housing 148 with sufficient force. Alternatively,one of the hub 123 and housing 148 may include an actuator or lock (notshown) that may be activated to separate the detents and/or otherwiseallow the cartridge 120 to be advanced relative to the positioningmember 140. Alternatively, the cartridge 120 and pusher member 130 maybe initially provided adjacent the distal end 144 of the positioningmember 140, as shown in FIG. 2B.

Optionally, the positioning member 140 and/or pusher member 130 mayinclude one or more elements that engage when the cartridge 120 reachesa predetermined location when advanced distally along the positioningmember 140, e.g., to limit subsequent proximal movement of the pushermember 130 relative to the positioning member 140. For example, as shownin FIGS. 2A and 2B, the positioning member 140 may include a lockingelement, e.g., a stepped-down region or recess 145 at a predeterminedlocation and the pusher member 130 may include a living hinge, tab, orother latch element 137 on the proximal end 132. Alternatively, thelocking element 145 may be a ring, tab, or other raised element (notshown) over which the latch element 137 may pass distally, yet maysubsequently engage the latch element 137 to prevent proximal movementof the pusher member 130, as shown in FIG. 3B(3) and described furtherbelow. For example, the latch element 137 may simply be an annular notchin the proximal end 132 of the pusher member 130 to bias the proximalend inwardly.

As an alternative to the latch element(s) 137, the pusher member 130 maysimply include a relatively narrow region on the proximal end 132.Further alternatively, the latch element(s) 137 may be replaced by aseparate collar or sleeve, one or more inwardly oriented detents, andthe like (not shown) attached to or otherwise formed on the proximal end132 of the pusher member 130. In an exemplary embodiment, the lockingelement 145 may be defined by a reduced diameter region on thepositioning member 140, e.g., formed by providing a larger tube around asmaller inner tube or by machining, etching, or otherwise removing aportion of the tubular body of the positioning member 140 distal to thereduced region. The pusher member 130 may include a correspondingelement (also not shown) that may allow distal advancement but preventproximal retraction once the pusher member 130 is advanced apredetermined distance, i.e., over the locking element 145. Exemplaryembodiments of cooperating elements are disclosed in U.S. PublicationsNo. 2006/0099238 and 2009/0088793, incorporated by reference herein.

The reduced region or other locking element 145 may be provided at apredetermined location on the positioning member 140, e.g., apredetermined distance from the positioning element 146 that correspondsto a length of the pusher member 130, e.g., a relaxed or compressedlength of the pusher member 130. As the cartridge 120 (and consequentlythe pusher member 130) is advanced over the positioning member 140,e.g., until the sealant 2 is disposed adjacent the positioning element146, the latch element 137 may pass freely over the locking element 145.Thereafter, the latch element 137 may prevent the pusher member 130 frombeing retracted again past the locking element 145 due to the blunt edgeof the latch element 137 abutting the locking element 145.

Alternatively, the pusher member 130 may be fixed relative to thepositioning member 140, for example, mechanically bonded, chemicallybonded, interference fit, and the like. For example, the distal end 134of the pusher member 130 may be fixed a predetermined distance proximalto the positioning element 146, e.g., to provide the sealant 2immediately adjacent the positioning element 146, as shown in FIG. 2B.Additional information on such alternatives and methods for making andusing them may be found in U.S. Publication No. 2008/0082122,incorporated by reference herein.

In one embodiment, the hub 123 of the cartridge 120 includes a tampingor auto advance device 200, depicted in detail in FIGS. 3A and 3B.Generally, the auto advance device 200 includes a slider tube 204slidable within the housing 202 and coupled to the cartridge 120. Theslider tube 204 may be biased distally relative to the housing 202 suchthat movement of the cartridge 120, sealant 2 (not shown, see FIG. 1A),and pusher tube 130 is initially coupled to the housing 202. Thus, whenthe hub 123 is directed distally, the cartridge 120, sealant 2, andpusher tube 130 are also directed distally. However, the slider tube 204may be movable proximally within the housing 202, e.g., when the bias isovercome, to allow the cartridge 120 to move proximally relative to thesealant 2 and pusher member 130, e.g., during deployment of the sealant2, as described further below.

As best seen in FIG. 3A(3), the proximal end 132 of the pusher member130 may be disposed within the housing 202 before the apparatus 101 isused. As shown in FIGS. 3A(1)-3A(3), the auto advance device 200 mayinclude an auto advance spring 206 adjacent the slider tube 204, e.g.,for biasing the slider tube 204 distally, yet allowing the slider tube204 to move proximally within the housing 202 when the spring bias isovercome. It will be appreciated that other springs or biasingmechanisms may be provided for biasing the slider tube 204 distallywithin the housing 202, yet allowing proximal movement relative to thehousing 202. In addition, as best seen in FIGS. 3A(1) and 3A(2), theauto advance device 200 may include auto advance spring support tubing208 fixed relative to the housing 202 and around which the auto advancespring 206 may be disposed. The slider tube 204 may slide over thesupport tubing 208 when the slider tube 204 is directed proximallywithin the housing 202.

In addition, the auto advance device 200 may include one or moreadditional components, e.g., coupled to the pusher member 130, cartridge120, and/or housing 202. For example, the pusher tube spring 210 may bedisposed between the secondary pusher member 230 and the proximal end132 of the pusher member 130. The pusher tube spring 210 may be coupledto the pusher member 130 and the secondary pusher member 230, e.g., byone or more of an interference fit, bonding with adhesive, and the like.In this embodiment, the proximal end 132 of the pusher member 130 ispositioned in the distal end 210 a of the tamping spring 210 and thedistal end of the secondary pusher member 230 is positioned within theproximal end 210 b of the tamping spring 210. Thus, the outsidediameters of the pusher members 130 and 230 are slightly less than theinside diameter of the tamping spring 210.

Optionally, the auto advance device 200 may include an inner cartridgeor tamping tube 212 disposed around the pusher tube spring 210 and thesecondary positioning member 230. As best seen in FIGS. 3A(1) and 3A(2),the inner cartridge 212 may be disposed concentrically within the slidertube 204. The inner cartridge 212 may be coupled to the slider tube 204such that the inner cartridge 212 moves with the slider tube 204. Forexample, the inner cartridge 212 may include a hub 212 a, which may bereceived in a corresponding pocket or recess 204 a in the slider tube204, thereby coupling movement of the inner cartridge 212 to the slidertube 204. The inner cartridge 212 may also protect and/or conceal thepusher tube spring 210 therein and may be coupled to the proximal end122 of the cartridge 120. As best seen in FIG. 3A(2), the innercartridge 212 may have an outer diameter similar to the diameter of thecartridge 120, e.g., such that the inner cartridge 212 abuts theproximal end 122 of the cartridge 120. Alternatively, the innercartridge 212 may be attached to the proximal end 122 of the cartridge120. In a further alternative, the inner cartridge 212 and cartridge 120may be provided as a single piece, e.g., such that the inner cartridge212 is merely an extension (not shown) extending proximally from thecartridge 120.

In FIGS. 3A(1)-3A(3), the auto advance device 200 is in an “inactive”position where the springs 206 and 210 are in extended or relativelyrelaxed states (best seen in FIG. 3A(2)). In the inactive position, theslider tube 204 may be biased by the auto advance spring 206 such that aflange 218 extending from the slider tube 204 abuts or otherwisecontacts a distal rib 214 of the housing 202, as best seen in FIG.3A(1). Thus, the slider tube 204 may be positioned in a distal portionof the housing 202 in the inactive position. In addition, in theinactive position, the support tubing 208 may be positioned proximallyto and/or substantially entirely outside of the slider tube 204, also asbest seen in FIG. 3A(1). As shown in FIG. 3A(3), the secondary pushermember 230 is located proximal to the locking element 145 in theinactive position, e.g., such that movement of the pusher member 130 andsecondary pusher member 230 are initially coupled to movement of thecartridge 120.

FIGS. 3B(1)-3B(3) show the auto advance device 200 in an “active”position where the springs 210 and 206 are compressed or in a relativelyhigher potential energy state. In the active position, the housing 202,including the cartridge 120, sealant 2, pusher member 130, and slidertube 204 have been advanced distally relative to the positioning member140 such that the secondary pusher member 202 has been advanced distallypast the locking element 145, as best seen in FIG. 3B(3). In the activeposition, the auto advance spring 206 is compressed between a proximalrib 216 of the housing 202 and the proximal end of the slider tube 204,and the slider tube 204 is positioned in a proximal portion of thehousing 202. For example, the cartridge 120 and hub 123 may be advancedrelative to the positioning member 140 until the cartridge 120 cannot beadvanced further, whereupon additional distal movement of the hub 123causes the auto advance spring 206 to compress as the slider tube 204(and proximal end 122 of the cartridge 120) moves proximally within thehousing 202. In addition, in the active position, the support tubing 208may extend into the slider tube 204 and abut the secondary pusher member230, thus compressing the tamping spring 210 as the pusher member 130moves proximally with the cartridge 120, as best seen by comparing FIG.3B(2) with FIG. 3A(2). When compressed, the tamping spring 210 applies adistal force against the pusher member 130, biasing the pusher member130 distally against the sealant 2. As explained further below, as thesealant 2 expands and/or softens, e.g., upon exposure to an aqueousenvironment, the constant force applied by the tamping spring 210 causesthe pusher member 130 to automatically advance distally, exertingconstant force on the sealant 2, thereby tamping or “cinching” thesealant 2 between the pusher member 130 and the positioning element 146during expansion. This method is described in greater detail below.

In the embodiment shown, the springs 210 and 206 are compression springsthat are in an expanded condition at their relatively relaxed lengthand/or lower potential energy state and are in a compressed conditionand/or higher potential energy state when a load is applied.Alternatively, instead of the compression springs 210 and 206, the autoadvance device 200 may include other spring arrangements or biasingmechanisms, such as an extension spring, leaf spring, and the like (notshown), e.g., that may be in a compressed condition at its lower energystate length and in an expanded condition when a load is applied.

Turning to FIGS. 4A-8B, an exemplary method is shown for sealing apuncture 90, e.g., using the system 10 described above to deliver asealant 2, e.g., to achieve hemostasis within the puncture 90.Generally, the puncture 90 extends from a patient's skin 92 throughintervening tissue 96, e.g., to a body lumen 94. In an exemplaryembodiment, the puncture 90 may be a percutaneous puncture communicatingwith a blood vessel 94, such as a femoral artery, carotid artery, andthe like.

In an exemplary method, the puncture 90 may be created using knownprocedures, e.g., using a needle, guidewire, one or more dilators, andthe like (not shown). Then, as depicted in FIGS. 4A and 4B, anintroducer sheath 20 may be advanced through the puncture 90 into thevessel 94, e.g., over a guide wire (not shown) placed through thepuncture 90 into the vessel 94. The introducer sheath 20 may provideaccess into the vessel 94 for one or more instruments, e.g., to allowone or more diagnostic, therapeutic, and/or other interventionalprocedures to be performed via the vessel 94. Upon completing theprocedure(s) via the vessel 94, any such instrument(s) may be removedfrom the puncture 90, leaving the introducer sheath 20 extending throughthe puncture 90 into the vessel 94.

The distal end 144 of the positioning member 140 may be introduced intothe puncture 90, e.g., through the lumen 26 of the introducer sheath 20,with the positioning element 146 in a collapsed condition, as shown inFIG. 4B. As shown in FIG. 4A, the cartridge 120 and cartridge hub 123,along with the sealant 2 and pusher member 130 (not shown in FIG. 4A forclarity, see, e.g., FIGS. 1A-2B), may be provided initially on theproximal end of the positioning member 140, e.g. near the positioningmember housing 148. Thus, the distal end 124 of the cartridge 120 mayinitially be located outside the puncture 90 when the positioning member140 is advanced into the puncture 90. Alternatively, the cartridge 120may be carried on the distal end 144 of the positioning member 140,e.g., as shown in FIG. 2B, such that the cartridge 120 (along with thesealant 2 and pusher member 130) is introduced simultaneously with thepositioning member 140, as described in U.S. Publication No.2008/0082122, incorporated by reference herein.

Still referring to FIGS. 4A and 4B, the distal end 144 of thepositioning member 140 may be inserted through the puncture 90 (via theintroducer sheath 20) and into the vessel 94. Optionally, thepositioning member 140 may include one or more markers (not shown) thatmay be disposed adjacent the proximal end 22 of the introducer sheath 20when the distal end 144 extends beyond the distal end 24 of theintroducer sheath 20, e.g., to provide a visual indication that thepositioning element 146 is disposed within the vessel 94 beyond thedistal end 24 of the introducer sheath 20. Once the positioning element146 is disposed within the vessel 94, i.e., beyond the distal end 24 ofthe introducer sheath 20, the positioning element 146 may be expanded toan enlarged condition, as shown in FIG. 4A and as shown in phantom inFIG. 4B. After expanding the positioning element 146, the positioningmember 140 may be at least partially withdrawn until the positioningelement 146 contacts the wall of the vessel 94 (shown in FIGS. 5A and5B), e.g., to substantially seal the vessel 94 from the puncture 90.

In an exemplary method, this may involve a two-step process (although itmay be completed in a single continuous action). First, with thepositioning element 146 expanded within the vessel 94, as shown in FIG.4A and in phantom in FIG. 4B, the positioning member 140 may bewithdrawn until the positioning element 146 contacts the distal end 24of the introducer sheath 20, which may provide a first tactile feedbackto the user (i.e., that the positioning element 146 has contacted theintroducer sheath 20, e.g., based upon the increased weight and/orresistance to proximal movement). After encountering the first tactilefeedback, the positioning member 140 may be withdrawn further until thepositioning element 146 contacts the wall of the vessel 94 and resistsfurther withdrawal, thereby providing a second tactile feedback. Theintroducer sheath 20 may be pulled proximally by the positioning element146 as the positioning member 140 is withdrawn, e.g., until thepositioning element 146 contacts the wall of the vessel 94 and thedistal end 24 of the introducer sheath 20 is withdrawn from the vessel94 into the puncture 90, as shown in FIGS. 5A and 5B.

Alternatively, a tension indicator assembly (not shown) may be used formore accurate control of the proximal tension on the positioning member140. Exemplary tension indicator assemblies are disclosed in co-pendingU.S. patent application Ser. No. 12/098,380, filed Apr. 4, 2008, andpublished as U.S. Publication No. 2009/0254110, the entire disclosure ofwhich is expressly incorporated herein by reference.

The desired amount of proximal tension may be maintained manually orusing a tension device (not shown) to provide temporary hemostasis,e.g., during the subsequent steps. Exemplary tension devices aredisclosed in co-pending U.S. patent application Ser. No. 10/806,952,filed Mar. 22, 2004 and published as US 2004/0267308, the entiredisclosure of which is expressly incorporated herein by reference.

Turning to FIGS. 6A and 6B, the cartridge 120 (carrying the sealant 2,shown in FIG. 6B) may then be advanced distally over the positioningmember 140 into the puncture 90, as indicated by arrow 164. For example,FIG. 6A illustrates the user grasping the hub 123 and pushing the hub123, e.g., to separate the hub 123 from the positioning member housing148 and advance the cartridge 120 distally over the positioning member140 and into the introducer sheath 20. The cartridge 120 may be advancedinto the introducer sheath 20 until the distal end 124 of the cartridge120 contacts the expanded positioning element 146, as shown in FIG. 6B.

In one embodiment, the cartridge 120 may be advanced through theintroducer sheath 20 until a hub 123 of the cartridge 120 abuts a hub 23on the introducer sheath 20. In another embodiment, the cartridge 120may be advanced until a locking element (not shown) engages, therebycoupling the cartridge 120 to the introducer sheath 20.

In the embodiment where the cartridge hub 123 includes the auto advancedevice 200, the auto advance device 200 is initially in the inactiveposition (not shown, see, e.g., FIGS. 3A(1)-3A(3)), during distaladvancement of the hub 123 and the cartridge 120. Thus, distaladvancement of the hub 123 causes corresponding advancement of thecartridge 120. Once the cartridge 120 contacts the expanded positioningelement 146, further distal advancement of the cartridge 120 isprevented by the positioning element 146.

Then, when the hub 123 is advanced further distally relative to thecartridge 120 the auto advance device 200 may be activated. For example,as shown in FIG. 6C, the cartridge 120 and hub 123 may be advanced untila marker 220 on the positioning member 140 becomes initially exposed,which may indicate that the distal end 124 of the cartridge 120 isadjacent to or in contact with the expanded positioning element 146. Atthis stage, as shown in FIGS. 3A(1)-3A(3), the slider tube 204 may be inthe distal position within the housing 202 of the hub 123. The hub 123may then be advanced further, e.g., at least partially over thecartridge 120, as shown in FIGS. 3B(1)-3B(3).

As shown in FIG. 6D, as the hub 123 is advanced, the marker 220 on thepositioning member 140 may become entirely exposed, thereby providing avisual indicator to the user confirming that the auto advance device 200has been activated. It will be appreciated that other visual and/oraudible indicators (not shown) may be provided on the positioning member140 and/or hub 123 to provide confirmation when the secondary pushermember 230 has been sufficiently advanced and/or the tamping spring 210has been compressed. Since the cartridge 120 is prevented from movingdistally, distal advancement of the hub 123 causes the slider tube 204,which is fixed to the cartridge 120, to slide into a proximal portion ofthe hub 123 so that the proximal end of the slider tube 204 contacts theproximal end of the hub 123, as shown in FIGS. 3B(1)-3B(3). Distaladvancement of the hub 123 further causes the auto advance spring 206 tocompress between the proximal end of the slider tube 204 and theproximal rib 216 of the housing 202. In the active position, the autoadvance spring support tubing 208 extends into the tamping tube 212,thereby pushing the secondary pusher member 230 towards the proximal end132 of the pusher member 130, which causes the tamping spring 210 tocompress. As the secondary pusher member 230 moves towards the proximalend 132 of the pusher member 130, the latch element 237 passes over theraised element 145 on the positioning member 140. Thereafter, thesecondary pusher member 230 is prevented from retracting proximallyrelative to the positioning member 140 and the compression of thetamping spring 210 is maintained, thus providing constant force to thesealant 2 via the pusher member 130.

Returning to FIGS. 6A and 6B, once the cartridge 120 and hub 123 havebeen advanced to place the sealant 2 in the desired position within thepuncture 90 (best seen in FIG. 6B), the cartridge 120 may be retracted,e.g., by pulling proximally on the hub 123, as indicated by arrow 165 inFIG. 7A. If the optional locking element (not shown) has coupled theintroducer sheath 20 to the cartridge 120, this action also withdrawsthe introducer sheath 20 from the puncture 90. Alternatively, theintroducer sheath 20 may be pulled, contacting the hub 123 and therebywithdrawing the cartridge 120 along with the introducer sheath 20. Asthe cartridge 120 is retracted, the pusher member 130 may remain inplace (e.g., due to the locking element 145) to prevent substantialproximal movement of the sealant 2, the sealant 2 is exposed within thepuncture 90, as shown in FIG. 7B. In one embodiment, as described above,when the cartridge 120 is retracted, the latch element 237 on thesecondary pusher member 230 may abut the locking element 145, therebypreventing substantial proximal retraction of the secondary pushermember 230 and the sealant 2 adjacent to the distal end 134 of thepusher member 130.

When the sealant 2 is exposed within the puncture 90, the sealant 2 maybe exposed to blood and/or other body fluids within the puncture 90.This exposure may cause the sealant 2 to absorb fluid, soften and/orexpand within the puncture 90, e.g., to provide hemostasis. The autoadvance device 200 may cause the pusher tube 130 to automaticallyadvance as space permits, e.g., when the sealant 2 begins to swelland/or soften, thereby compressing or “cinching” the sealant 2 betweenthe pusher tube 130 and the positioning element 146. Optionally, ifdesired, the pusher member 130 may be advanced manually to compress thesealant 2 further, e.g., against the positioning element 146. This maycause the sealant 2 to expand further radially outwardly and/or pressthe sealant 2 against the arteriotomy, e.g., to enhance sealing thepuncture 90 from the vessel 94. Optionally, the pusher member 130 mayinclude one or more distance markers (not shown) on or adjacent theproximal end 132, and the pusher member 130 may be advanced into thepuncture 90 a desired distance, which may be confirmed by monitoring thedistance markers.

Once the sealant 2 has been exposed for sufficient time and/or tamped bythe pusher member 130, the positioning element 146 may be collapsed, andthe positioning member 140 withdrawn from the vessel 94 and puncture 90,e.g., by pulling the collapsed positioning element 146 through thesealant 2 and pusher member 130, as depicted by arrow 166 in FIG. 8A. Inan exemplary embodiment, the expandable member 146 may have a profilenot more than about 0.875 millimeter (035 inch) to facilitate removal ofthe positioning member 140 without substantially disturbing the deployedsealant 2. The pusher member 130 may be maintained substantiallystationary during withdrawal of the positioning member 140, e.g., toprevent migration and/or dislodgment of the sealant 2 within thepuncture 90. For example, as shown in FIG. 8A, the pusher member 130 maybe maintained substantially stationary by a user grasping the pushermember 130 during withdrawal of the positioning member 140. In theembodiment where the system 10 includes the auto advance device 200, theuser may grasp the pusher member 130 rather than the secondary pushermember 230 so that the user may have more control of the force appliedto the sealant 2 during withdrawal of the positioning member 140. Inaddition, in embodiments where the sealant 2 includes an adherent layer,the “sticky” adherent layer may also aid in securing the sealant 2 tothe surrounding tissue. Once the positioning member 140 is completelyremoved, the pusher member 130 may be removed from the puncture 90,leaving the sealant 2 within the puncture 90, as shown in FIG. 8B.

Optionally, after removing the positioning member 140, liquid hydrogelor other sealing compound, or other material may be delivered into thepuncture 90, e.g., above and/or around the sealant 2, to assist inachieving hemostasis. For example, such material may be delivered viathe lumen 136 of the pusher member 130 and/or by introducing anotherdelivery device (not shown) into the puncture 90, e.g., after removingthe pusher member 130.

Turning now to FIGS. 9-11B, another exemplary embodiment of an apparatus301 is shown for delivering a sealant 302 into a puncture through tissueincluding a tamping device 385. Similar to other embodiments herein, theapparatus 301 is shown schematically and not to scale, e.g., with theradial and axial dimensions exaggerated to facilitate identification ofthe components of the apparatus 301. The apparatus 301 includes anelongate positioning or occlusion member 340, a cartridge 370, and acatheter hub 380. The positioning member 340 includes a proximal end342, a distal end 344, and an expandable positioning element 346, e.g.,similar to previous embodiments, on the distal end 344. Similar toprevious embodiments, optionally, a transition cuff 350 may be locatedadjacent to the distal end of the expandable member 346.

The cartridge 370 generally includes an outer tubular member 373, asealant 302, an inner pusher member 330, and a middle hub 376. The outertubular member 373 includes a lumen 360 extending between a proximal end372 and a distal end 374 thereof. The outer tubular member 373 ismovable relative to the inner pusher member 330, which is slidablydisposed within the outer tubular member 373. The middle hub 376 may beattached to the proximal end 372 of the outer tubular member 373.

The sealant 302 and inner pusher member 330 are similar to previousembodiments. The inner pusher member 330 includes a lumen extendingbetween a proximal end 332 and a distal end 334. The inner pusher member330 may include a peel away lock 390 or detents 336, e.g., as shown inFIGS. 10A-10B, for initially limiting proximal movement of the outertubular member 373, e.g., until after removing the lock 390.

The middle hub 376 includes a main cylinder 371, a first conical surface377 a, and a second conical surface 377 b. A latching detent 375 isdisposed between the first and second conical surfaces 377 a, 377 b. Themain cylinder 371 includes a proximal ridge 371 a, and a distal surface371 b. The first conical surface 377 a is tapered from the proximalridge 371 a to the latching detent 375. The distal end of the secondconical surface 377 b includes a diameter larger than the proximal endof the first conical surface 377 a thereby creating the latching detent375. Alternatively, the first conical surface 377 a may be tapered usingmultiple angles or may be tapered gradually.

The catheter hub 380 includes an outer housing 380 a including proximaland distal ends 382, 384 that are substantially fixed relative to theproximal end 342 of the positioning member 340. For example, thecatheter hub 380 may include an inner housing 380 b fixed relative tothe outer housing 380 a and coupled to a handle or balloon inflator 396on the positioning member 340. The hub 380 may also include a tampingdevice 385, latch 387, and a tamping spring 381 disposed between thetamping device 385 and the balloon inflator 396. The catheter hub 380may further include centering surfaces 386, e.g., on the inner housing380 b. The material of the catheter hub 380 and other components may beformed from suitable durable plastics, metals, and/or compositematerials. During operation of the apparatus 301, the interior of thehandle or balloon inflator 396 may communicate via a lumen (not shown)of the positioning member 340 with the interior of the expandable member346 to provide a fluid to expand the expandable member 346, e.g.,similar to other embodiments described elsewhere herein. Optionally, thehandle 396 may include a tension indicator (not shown), e.g., alsosimilar to the other embodiments described herein.

The tamping device 385 includes a proximal surface 385 a, a distalsurface 385 b, a proximal nub 385 c, and a recess 385 d. The recess 385d extends partially through the tamping device 385 between the distalsurface 385 b and a most distal portion 385 e of proximal nub 385 c. Therecess 385 d is sized to receive the proximal end 332 of the innerpusher member 330 therein without allowing the inner pusher member 330to pass entirely through the tamping device 385.

The latch 387 includes a proximal arm 387 a, a distal arm 387 b, and anintermediate arm 387 c. The proximal, distal, and intermediate arms 387a, 387 b, 387 c each include a proximal, distal, and intermediate tip388 a, 388 b, 388 c, respectively. The distal tip 388 b may be shaped tomate with the latching detent 375 of the middle hub 376, and theintermediate tip 388 c may be shaped with a nub for making initialcontact with the proximal end 378 of the middle hub 376. A circularspring clip 383 abuts the proximal arm 387 a to bias the proximal arm387 a radially inwardly (away from the inner housing 380 b. The inwardlybiased proximal arm 387 a causes the proximal tip 388 a to preventdistal movement of the tamping device 385 when the latch 387 is in theposition shown in FIG. 9.

The centering surfaces 386 are located proximally to the distal end 384.The centering surfaces 386 may be conically shaped and/or otherwisesized and/or shaped for cooperating with conical surfaces 377 a, 377 bon the middle hub 376. The cooperation of centering surfaces 386 withconical surfaces 377 a, 377 b provides automatic centering duringengagement of the middle hub 376 to the catheter hub 380.

FIG. 9 shows the apparatus 301 in a first position, e.g., where thecartridge 370 is disposed adjacent a distal end 344 of the positioningmember 340. This first position may be a configuration in which theapparatus 301 is delivered from a manufacturer to a user. In the firstposition, the transition cuff 350, if included, is fully extended overthe distal end 374 of the outer tubular member 373. Further, in thefirst position, the expandable member 346 may be fully disposed withinthe lumen 376 of the outer tubular member 373, the tamping device 385may rest against the proximal tip 388 a of the proximal arm 387 a, andthe tamping spring 381 may be compressed.

Turning to FIG. 10A, the apparatus 301 of FIG. 9 is shown in a secondposition limited by a peel away lock 390. Alternatively, the apparatus301 may be provided to the user initially in the second position, i.e.,with the cartridge 370 disposed adjacent the catheter hub 380 butwithout activating the tamping device 385. For example, proximalmovement of the cartridge 370 into the catheter hub 380 past the secondposition may be prevented until the peel away lock 390 is removed. Thepeel away lock 390 includes a passage extending between a proximal end392 and a distal end 394 that surrounds the inner pusher member 330. Thepeel away lock 390 may be disposed between the proximal end 378 of themiddle hub 376 and the distal surface 385 b of the tamping device 385.In the second position, the cartridge 370 may be positioned proximallyrelative to the expandable member 346 such that the expandable member346 is fully exposed distal to the distal end 374. In addition, in thesecond position, the distal end of the sealant 302 may be disposedadjacent the distal end 374 of the cartridge 370, and the latch 387 mayremain in contact with the distal surface 385 b of the tamping device385.

Turning to FIG. 10B, an alternative embodiment of the apparatus 301′ isshown that is generally similar to the embodiment of FIGS. 9 and 10A.Similar to FIG. 10A, the apparatus 301′ is shown in the second position;however, unlike the apparatus 301 that is only limited from furtherproximal movement, the apparatus 301′ is positively locked in the secondposition by a locking bar 379 a.′ The apparatus 301′ also includes amodified middle hub 376′ and a modified inner pusher member 330.′ Themodified middle hub 376′ includes a pushbutton 379′ coupled to thelocking bar 379 a.′ The pushbutton 379′ and the locking bar 379 a′ aredisposed within a lumen 379 b′ extending between an outer and innersurface of the main cylinder 371.′ The pushbutton 379′ may be springloaded to bias the locking bar 379 a′ into a detent 336′ on the pushermember 330.′ The pushbutton 379,′ familiar to those of ordinary skill inthe art, may be a single action type or a double action type used toretract the locking bar 379 a′ from the detent 336.′ The spring loadedlocking bar 379 a′ may be extended into the detent 336′ when thepositioning member 340,′ sealant 302,′ and inner pusher member 330′ areadvanced in a distal direction until the locking bar 379 a′ aligns withthe detent 336.′ The locking bar 379 a′ prevents further proximalmovement of the cartridge 370′ until the pushbutton 379′ is pressed toretract the locking bar 379 a.′ As shown, in the second position, thetamping device 385′ remains in contact with the latch 387.′

Turning now to FIG. 11A, after removing the lock 390, the apparatus 301of FIGS. 9 and 10A is shown in a third position, i.e. at a triggerpoint, which is a frozen instant in time when the tamping device 385 isinitially activated. After releasing the cartridge 370, e.g., byremoving the lock 390 or releasing the pushbutton 379,′ the cartridge370 may be moved proximally to expose the sealant 302. As the cartridge370 enters the catheter hub 380, the conical surfaces 377 a, 377 b mayengage the centering surfaces 386 to align the middle hub 376 with thecatheter hub 380. The proximal end 378 of the middle hub 376 firsttouches the intermediate tip 388 c of the intermediate arm 387 c,causing the latch 387 to rotate. The latch contact generally occursbefore the conical surfaces 377 a, 377 b and the centering surfaces 386have fully engaged each other.

Continued proximal movement of the cartridge 370 into the catheter hub380 to expose the sealant 302 causes the proximal arm 387 a and proximaltip 388 a to rotate upward away from the tamping device 385, therebyreleasing the tamping device 385, as explained further below. Also atthe trigger point, the distal arm 387 b and distal tip 388 b may rotatedown into the latching detent 375 to secure the middle hub 376 to thecatheter hub 380, thereby securing the cartridge 370 relative to thecatheter hub 380 in a latched position.

As shown in FIG. 11A, the expandable member 346 may have been previouslyexpanded and at least partially withdrawn within a body lumen (notshown) as discussed elsewhere herein until the expanded expandablemember 346 substantially seals the body lumen from a puncture (also notshown).

Turning now to FIG. 11B, the apparatus 301 is shown in a third positionafter the trigger point of FIG. 11A, i.e., with the sealant 302 beingtamped and/or compressed. The sealant 302 is tamped between the distalend 334 of the inner pusher member 330, which is biased to movedistally, and the expanded expandable member 346. As can be seen, thetamping device 385 is released when the latch 387 is rotated todisengage the proximal arm 387 a from the distal surface 385 b of thetamping device 385. The tamping spring 381 biases the inner pushermember 330 distally because the proximal end 332 of the inner pushermember 330 is disposed within the recess 385 d, thereby biasing thedistal end 334 of the inner pusher member 330 distally to compress thesealant 302 towards the expandable member 346 (and/or against anarteriotomy, not shown). The outer surface of the tamping device 385maintains the proximal arm 387 a in an upwardly rotated position,thereby preventing the latch 387 from moving from the latched position.

Thereafter, once the sealant 302 is sufficiently compressed and/orhydrated within the puncture, the catheter hub 380 may be pulledproximally, thereby withdrawing the cartridge 370 from the puncture,leaving the inner pusher member 330 and sealant 302 within the puncturearound the positioning member 340, similar to the previous embodiments.The expandable member 346 may then be collapsed and the positioningmember 340 removed through the sealant 302 and inner pusher member 330,also similar to the previous embodiments. Finally, the inner pushermember 330 may be removed, leaving the sealant within the puncture.

Turning now to FIG. 12A-12C, an alternative embodiment of an apparatus401 is shown for sealing a puncture. The apparatus 401 generallyincludes an elongate occlusion or positioning member 440, a cartridge470, and a catheter hub 480, similar to the previous embodiments. Thepositioning member 440 is generally similar to those described elsewhereherein and includes a proximal end 442, a distal end 444, and anexpandable member 446. Optionally, the apparatus 401 may include atransition cuff (not shown), similar to those described elsewhereherein.

The cartridge 470 includes an outer tubular member 473, a middle hub476, and a lumen 460 extending between a proximal end 472 and distal end474 thereof. A sealant 402 and an inner pusher member 430 are disposedwithin the outer tubular member 473, generally similar to the previousembodiments. The inner pusher member 430 includes a lumen extendingbetween a proximal and distal end 432, 434. The middle hub 476 may besimilar to the previous embodiments, e.g., including a main cylinder471, first conical surface 477 a, and second conical surface 477 b. Alatching detent 475 may be provided, e.g., between the first and secondconical surfaces 477 a, 477 b, also similar to the previous embodiments.The middle hub 476 may also include a pushbutton 479 and/or locking bar479 a for cooperating with a detent 436, similar to the previousembodiments.

The catheter hub 480 generally includes a body or outer housing 480including proximal and distal ends 482, 484. The body 480 mayadditionally include a handle or balloon inflator 496, tamping device485, latch gate 487, and tamping spring 481 disposed between the tampingdevice 485 and the balloon inflator 496. A trigger pin 498 is coupledbetween the body 480 and the latch gate 487. The trigger pin 498includes a proximal end 498 a, an intermediate member 498 b, and adistal end 498 c. The intermediate member 498 b is sized smaller thanthe proximal and distal ends 498 a, 498 c for releasing the latch gate487. The body 480 may further include centering surfaces 486. Theballoon inflator 496 may be similar to those described elsewhere herein.The latch gate 487 may be initially offset vertically down in the body480, e.g., with lower and upper ends 487 a, 487 b disposed in lower andupper guiding grooves 488 a, 488 b. A channel 487 c is included in thelatch gate 487 for receiving the proximal end 498 a of the trigger pin498. A cavity and spring (both not shown) in the body 480 may also beincluded for receiving the proximal end 498 a. A leaf spring 483 may beused to bias the latch gate 487 in a downward direction.

FIG. 12A shows the apparatus 401 in a second position, similar to theapparatus 301 shown in FIG. 10A. Prior to the second position, theapparatus 401 may have been provided initially in a first position,similar to the first position of the apparatus 301 shown in FIG. 9, orthe apparatus 401 may be provided already in the second position. In thefirst and second positions, the compressed tamping spring 481 may biasthe tamping device 485 into contact with the latch gate 487. In thesecond position, the cartridge 470 may be retracted proximally until theexpandable member 446 is fully exposed distal to the distal end 474 andthe locking bar 479 a is extended into detent 436 in the pusher member430.

In FIG. 12B, a snapshot of an instant in time illustrates a triggerpoint of the apparatus 401, similar to the trigger point of the previousembodiments. At the trigger point, the middle hub 476 may be coupled tothe catheter hub 480. For example, the conical surfaces 477 a, 477 b mayengage the centering surfaces 486 to align the middle hub 476 within thecatheter hub 480 as the middle hub 476 enters the catheter hub 480. Themiddle hub 476 displaces the trigger pin 498 proximally until theintermediate member 498 b is positioned in the channel 487 c of thelatch gate 487, thereby allowing the latch gate 487 to lower and thetamping device 485 to advance distally due to the force of the tampingspring 481. The latch gate 487 is lowered due to the bias of the leafspring 483. During use, the expandable member 446 may be expanded and atleast partially withdrawn similar to earlier embodiments until theexpanded expandable member 446 substantially seals a body lumen from apuncture, thereby placing the sealant 402 within the puncture adjacentthe body lumen.

Turning to FIG. 12C, the apparatus 401 is shown in a third position withthe tamping device 485 fully displaced and the tamping spring 481extended. The sealant 402 is compressed between the distal end 434 ofthe inner pusher member 430 and the expanded expandable member 446(and/or tissue above the arteriotomy) due to the displacement of thetamping device 485 distally. Cooperating connectors (not shown) on themiddle hub 476 and the distal end 484 of the body 480 may be used tocouple the middle hub 476 to the catheter hub 480 upon activation,similar to the previous embodiments.

Turning to FIG. 13, still another alternative embodiment of an apparatus501 is shown for sealing a puncture similar to the apparatus 401 ofFIGS. 12A-12C. The apparatus 501 includes a cartridge 570, and acatheter hub 580 similar to the previous embodiments. The apparatus 501includes a hub latch 552 for displacing the latch gate 587. The hublatch 552 may include a leaf spring (not shown) for biasing the hublatch 552 in an upward direction, thereby displacing the latch gate 587in an upward direction.

In FIG. 13, the apparatus 501 is shown in a third position similar toFIGS. 11B and 12C, where a tamping spring 581 is extended, similar toprevious embodiments. Previously, the apparatus 501 may have been in aninitial first position (not shown), and/or a second position (notshown), where the tamping spring 581 is compressed, also similar to theprevious embodiments. In the third position, as shown, the middle hub576 is fully mated with the catheter hub 580. Further, the trigger pin598 is displaced proximally to release the latch gate 587 to bedisplaced upward by the raised hub latch 552, the hub latch 552 beingraised by a leaf spring (not shown) or similar expanding device. Thedistal tip 552 a of the raised hub latch 552 may be coupled to thelatching detent 575 to secure the middle hub 576 to the catheter hub580.

An expandable member 546 may be expanded and at least partiallywithdrawn similar to earlier embodiments until the expanded expandablemember 546 substantially seals a body lumen from a puncture. A sealant502 is compressed between the expanded expandable member 546 and aninner pusher member 530 affected by a full distal displacement of atamping device 585 by the tamping spring 581.

Turning to FIG. 14, yet another alternative embodiment of an apparatus601 is shown for sealing a puncture similar to the apparatus 401 ofFIGS. 12A-12C. The apparatus 601 includes an elongate occlusion orpositioning member 640, a cartridge 670, and a catheter hub 680,generally similar to the previous embodiments. The apparatus 601 mayfurther include a hub latch 652 attached to a distal end 698 b of atrigger pin 698. The hub latch 652 includes a first and second tip 652a, 652 b. The trigger pin 698 includes a displacement spring 683 forbiasing the trigger pin 698. The displacement spring 683 may be disposedwithin an enclosure 654 of the catheter hub 680.

The apparatus 601 is shown in a third position, where a tamping spring681 is extended, similar to the previous embodiments. Previously, theapparatus 601 may have been in an initial first position, and/or asecond position (neither shown), where the tamping spring 681 iscompressed, similar to the previous embodiments. In the third position,a middle hub 676 is fully mated with the catheter hub 680. Further, thefirst tip 652 a of hub latch 652 is mated with the latching detent 675and the second tip 652 b is displaced proximally by a proximal end 678of the middle hub 676. The proximal displacement of the second tip 652 balso proximally displaces the trigger pin 698 to release the latch gate687, the latch gate 687 being biased upward by a leaf spring (not shown)or similar expanding member. The upwardly displaced latch gate 687releases the tamping device 685 to be distally displaced by the tampingspring 681.

The expandable member 646 may be expanded and at least partiallywithdrawn similar to earlier embodiments until the expanded expandablemember 646 substantially seals a body lumen from a puncture. The sealant602 is compressed between the expanded expandable member 646 and theinner pusher member 630 affected by full distal displacement of atamping device 685 by the tamping spring 681.

Turning now to FIG. 15A-15C, yet another embodiment of an apparatus 701is shown for sealing a puncture. The apparatus 701 includes an elongateocclusion or positioning member 740, a cartridge 770, and a catheter hub780. The positioning member 740 may be similar to those describedelsewhere herein and includes a proximal end 742, a distal end 744, andan expandable member 746. Additionally, the positioning member 740 mayinclude a ring 748 sized for displacing an inner pusher member 730, asdescribed further below.

The cartridge 770 includes an outer tubular member 773, and a middle hub776. The outer tubular member 773 includes a lumen 760 extending betweena proximal end 772, and distal end 774 thereof. A sealant 702 and innerpusher member 730 are disposed within the outer tubular member 773. Theinner pusher member 730 includes a lumen extending between a proximaland distal end 732, 734. The middle hub 776 is similar to previousembodiments and includes a main cylinder 771, first conical surface 777a, and second conical surface 777 b. Included between the first andsecond conical surfaces 777 a, 777 b is a latching detent 775. Themiddle hub 776 may also include a pushbutton and a locking bar (both notshown) for cooperating with a detent (also not shown) in the innerpusher member 730, similar to the previous embodiments, e.g., to preventproximal movement of the cartridge 770 until the pushbutton (not shown)is pressed. In addition or alternatively, the apparatus 701 may includea peel away lock (not shown) to prevent proximal movement of thecartridge 770.

The catheter hub 780 generally includes a body or outer housing 780including proximal and distal ends 782, 784. The body 780 includes aballoon inflator 796, tamping device 785, and lower and upper tampinglatches 752, 754. The body 780 may further include centering surfaces786, lower and upper hub latches 756, 758, and carriage 753. A circularspring clip 783 is used to bias the lower and upper tamping latches 752,754 in a radially inward direction. The carriage 753 includes lower andupper release slots 755 a, 755 b for displacing the tamping latches 752,754 in an outward direction when the carriage 753 is displaced in aproximal direction. A tamping spring 781 is compressed between thetamping device 785 and the balloon inflator 796.

FIG. 15A shows the apparatus 701 in a second position. Prior to thesecond position, the apparatus 701 may have occupied a first position(not shown) similar to the first position described in previousembodiments. In the second position, the positioning member 740 isadvanced distally until the expandable member 746 is fully exposeddistal to the distal end 774. A pushbutton (not shown) and locking bar(not shown) may be used with a cooperating detent (not shown) on theinner pusher member 730, e.g., as described in the previous embodiments,to secure the apparatus 701 in the second position.

FIG. 15B is a snapshot of an instant in time illustrating a triggerpoint of the apparatus 701. As shown, at the trigger point, the middlehub 776 is coupled with the catheter hub 780, and the conical surfaces777 a, 777 b have mated with the centering surfaces 786. The middle hub776 has displaced the carriage 753 proximally thereby rotating thetamping latches 752, 754 outwardly away from the tamping device 785. Theoutwardly rotating tamping latches 752, 754 cause the proximal ends ofhub latches 756, 758 to rotate downwardly to a latch position to matewith latching detents 775. The tamping device 785 is then free torelease in the distal direction. The expandable member 746 may beexpanded and at least partially withdrawn similar to earlier embodimentsuntil the expanded expandable member 746 substantially seals a bodylumen from a puncture.

Turning to FIG. 15C, the apparatus 701 is shown in the third positionwith the tamping device 785 fully displaced distally and the tampingspring 781 extended, thus compressing or tamping the sealant 702 betweenthe inner pusher member 730 and the expanded expandable member 746. Thedisplacement of the tamping device 785 forces the ring 748 to distallydisplace the inner pusher member 730. The middle hub 776 is secured tothe catheter hub 780 by the downwardly rotated hub latches 756, 758,which are maintained in the latch position by the outwardly rotatedtamping latches 752, 754. Distal tips 752 a, 754 a of tamping latches752, 754 rest in contact with an outer surface of the carriage 753.Construction and operation of these embodiments generally proceedsimilar to one another.

While the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the invention is not to be limited to the particular formsor methods disclosed, but to the contrary, the invention is to cover allmodifications, equivalents, and alternatives falling within the scope ofthe appended claims.

1. An apparatus for sealing a puncture extending through tissue,comprising: an elongate member comprising a proximal end, a distal endsized for insertion into a puncture through tissue, and an expandablemember on the distal end; a cartridge comprising a housing on a proximalend thereof, a distal end sized for insertion into the puncture, and alumen extending between the proximal and distal ends sized for receivingthe elongate member therein; a sealant disposed within the cartridgelumen adjacent the cartridge distal end; a pusher member disposed withinthe cartridge lumen adjacent to the sealant; and a tamping devicecomprising: a slider tube within the housing and coupled to thecartridge, the slider tube being slidable relative to the housing; anauto advance spring compressible between the slider tube and a proximalsurface of the housing; and a tamping spring disposed within the slidertube and coupled between the pusher member and a secondary pusher tube.2. The apparatus of claim 1, further comprising an auto advance springtube within the housing, the auto advance spring surrounding the autoadvance spring tube.
 3. The apparatus of claim 1, wherein the slidertube is slidable between an inactive position and an active position,the pusher tube being biased to move distally relative to the cartridgein the active position for compressing the sealant.
 4. The apparatus ofclaim 3, wherein, in the inactive position, the tamping spring and theauto advance spring are substantially relaxed.
 5. The apparatus of claim1, wherein, in the active position, the tamping spring and the autoadvance spring store potential energy for biasing the pusher tube tomove distally.
 6. The apparatus of claim 1, wherein the cartridge ismovable along the elongate member from a proximal position wherein thecartridge is disposed adjacent the elongate member proximal end to adistal position wherein the sealant is disposed adjacent the expandablemember and the tamping device is activated to bias the pusher member tomove distally to push the sealant towards the expandable member, andwherein the slider member is biased to a first position within thehousing such that the slider member moves distally with the housing whenthe cartridge is directed towards the distal position, but movableproximally within the housing to a second position when the cartridge isadvanced to the distal position, thereby compressing the spring memberto bias the pusher member to move distally.
 7. The apparatus of claim 6,wherein the expandable member is expandable to an expanded state beforethe cartridge is advanced to the distal position such that the sealantis compressed between the pusher member and the expanded expandablemember when the tamping device is activated.
 8. The apparatus of claim6, wherein the elongate member and pusher member comprise cooperatingfeatures that engage with one another when the cartridge is advanced tothe distal position to prevent subsequent proximal movement of thepusher member relative to the elongate member.
 9. The apparatus of claim6, wherein the tamping device further comprises a support member fixedin the housing that is coupled to the pusher member when the cartridgeis advanced to the distal position and the slider member moves to thesecond position, thereby engaging cooperating features on the pushermember and elongate member to prevent subsequent proximal movement ofthe pusher member relative to the elongate member.
 10. The apparatus ofclaim 6, further comprising a marker on the elongate member forindicating that the tamping device is in an active position.
 11. Theapparatus of claim 6, wherein the tamping spring is configured fordistally advancing the pusher member thereby compressing the sealantbetween the pusher member and the expandable member when the expandablemember is expanded.